Senior Manufacturing & Quality Engineer – Medical Devices & Consumer Electronics

• Bachelor's or Master's Degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related engineering discipline.
• Minimum 9+ years of professional experience, preferably with 10+ years in manufacturing process support, manufacturing engineering, or quality engineering roles.
• Proven experience taking hardware products from product development through NPI and mass production in high-volume manufacturing environments.
• Strong experience in consumer electronics and/or electro-mechanical medical device manufacturing.
• Hands-on knowledge of manufacturing and qualification processes including injection molding, metal fabrication, electronic components, SMT, batteries, FATP, and packaging.
• Extensive experience working with EMS contract manufacturers under CM, JDM, ODM, and/or OEM models.
• Strong understanding of EVT, DVT, PVT, and Mass Production phase-gate methodologies, including pFMEA and process validation.
• Practical experience with QMS, CAPA, supplier quality management, and quality compliance for medical devices, preferably Class II or Class III products.
• Knowledge of relevant medical device standards and regulatory requirements, including FDA and ISO 13485.
• Proven ability to lead cross-functional projects involving yield improvement, cost reduction, process validation, and manufacturing efficiency.
• Strong analytical and problem-solving capabilities, including practical use of structured quality tools such as the 7 QC tools.
• Working knowledge of embedded systems and functional testing is an advantage.
• Ability to collaborate effectively across Manufacturing, Mechanical Engineering, Electrical Engineering, Quality, Supply Chain, Product, and Contract Manufacturing teams.
• Strong ability to simplify complex technical issues and communicate them effectively to non-technical stakeholders.
• Self-driven, proactive, adaptable, and comfortable working in a fast-paced and dynamic environment.
• Willingness and ability to travel regionally as required.
• Proficiency with Google Workspace and Slack is preferred.
• Knowledge or experience in AI and CAD is an added advantage.
• Fluency in English, Mandarin Chinese, and Malay is required, both written and verbal.

Originally posted on Himalayas